(Section C, Topical Oxygen) (CAG-00060R)
The Centers for Medicare & Medicaid Services (CMS) received a reconsideration request to remove the coverage exclusion of Continuous Diffusion of Oxygen Therapy (CDO) from NCD Manual 20.29, Section C. This section of the NCD (Topical Application of Oxygen) considers treatment known as CDO as the application of topical oxygen and nationally non-covers this treatment.
After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors.
Summary:
Chronic wounds are prevalent in the Medicare population and cause a disproportionate burden on beneficiaries and their families and caretakers. CMS recognizes the need for new therapies that will heal wounds and the standardization of wound care in general. Overall, since the evidence on chronic wound healing from topical oxygen therapies has increased over the past few years, CMS believes a national non-coverage decision is no longer appropriate. CMS received 17 public comments and most of the commenters support this position. However, given the inability to identify the characteristics of chronic wounds that best respond to topical oxygen therapy and the type of patients’ best suited to use this therapy, we are not able to define a patient population that would benefit from topical oxygen therapy in a national coverage determination at the present time. Ongoing research in the US and Europe and pending publications may provide additional evidence that may support a national determination in the future. CMS realizes that double blinded RCTs cannot always be used in order to answer questions regarding the outcomes of exposure to various treatment regimens in the wound care space. However we acknowledge that various investigative groups have, and are currently, studying the treatment of chronic wounds by TOT through randomized controlled trials. CMS reviewed a number of articles from commenters, considered all additional information and has determined to finalize the proposed decision.
Conclusion
The Centers for Medicare & Medicaid Services (CMS) received a reconsideration request to remove the coverage exclusion of Continuous Diffusion of Oxygen Therapy (CDO) from NCD Manual 20.29, Section C. This section of the NCD (Topical Application of Oxygen) considers treatment known as CDO as the application of topical oxygen and nationally non-covers this treatment.
After examining the evidence, CMS has decided that no National Coverage Determination is appropriate at this time concerning the use of topical oxygen for the treatment of chronic wounds. We will amend NCD 20.29 by removing Section C, Topical Application of Oxygen and Medicare coverage of topical oxygen for the treatment of chronic wounds will be determined by the local contractors.